Trials@uspto.gov
`571.272.7822
`
`Paper 13
`Entered: November17, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNGBIOEPIS CO., LTD.,
`Petitioner,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK,and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`DECISION
`Granting Institution ofInter Partes Review
`35 US.C. $314
`
`
`571.272.7822
`
`Paper 13
`Entered: November17, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNGBIOEPIS CO., LTD.,
`Petitioner,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK,and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`DECISION
`Granting Institution ofInter Partes Review
`35 US.C. $314
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`I.
`
`INTRODUCTION
`
`Regeneron Pharmaceuticals, Inc. (“Patent Owner’) is the ownerof
`
`U.S. Patent 11,253,572 B2 (“the °572 patent’). Paper 5, 1. On April 27,
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`2023, Samsung Bioepis Co., Ltd. (“Petitioner”) filed a Petition for inter
`
`partes review challenging the patentability of claims 1—30 (all claims) ofthe
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`°572 patent. Paper 2, 1 (“Pet.”). On August 25, 2023, Patent Ownerfiled a
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`Preliminary Responseto the Petition. Paper 7 (“Prelim. Resp.”). With our
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`authorization (see Ex. 3001), Petitionerfiled a Reply to the Preliminary
`
`Responseto address the issue ofthe priority date to be accorded the *572
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`patent asit relates to asserted references, and Patent Ownerfiled a respective
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`Sur-Reply.
`
`Under 37 C.F.R. § 42.4(a), we have authority to determine whetherto
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`institute trial in an interpartes review. We mayinstitute an interpartes
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`review if the information presentedin the petition filed under 35 U.S.C.
`
`§ 311, andanypreliminary responsefiled under § 313, showsthat there is a
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`reasonablelikelihood that Petitioner would prevail with respect toat least
`
`one of the claims challenged in the petition. 35 U.S.C. § 314.
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`After reviewing the parties’ submissionsin view ofthe preliminary
`
`record, we conclude Petitioner demonstrates a reasonable likelihood it would
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`prevail in showingthat at least one challenged claim ofthe ’572 patent is
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`unpatentable underthe presented grounds. Therefore, we grantinstitution of
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`interpartes review. We note that there are disputed issuesin this
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`proceeding under 35 U.S.C. § 325(d) and § 314(a) concerning discretionary
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`denial; however, we determineinstitution should be not be denied. See Pet.
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`63-68; Prelim. Resp. 49-62. Our reasoningis discussed below.
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`
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`IPR2023-00884
`Patent 11,253,572 B2
`
`A.
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`REAL PARTIES-IN-INTEREST
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`Each party identifies only itself'as areal party-in-interest. Pet. 6;
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`Paper3, 1.
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`B.|RELATED MATTERS
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`Petitioner identifies the following regarding related matters:
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`IPR2022-01524 concerning the °572 patent(institution denied);
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`IPR2021-00881 concerning U.S. Patent 9,254,338; IPR2021-00880
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`concerning U.S. Patent 9,669,069; IPR2022-01225 concerning U.S. Patent
`
`10,130,681; IPR2023-00442 also concerning U.S. Patent 10,130,681;
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`IPR2022-01226 concerning U.S. Patent 10,888,601, to which
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`IPR2023-00566is joined; IPR2023-00739 also conceming U.S. Patent
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`10,888,601; Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals
`
`Inc., NDWV-1-22-cv-00061 (NDWYV); and United States v. Regeneron
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`Pharms., Inc., No. 1:20-cv-11217-FDS(D. Mass. ).
`
`Patent Owneridentifies the same matters and adds: IPR2023-00532
`
`also concerning U.S. Patent 10,130,681; IPR2022-00257 and
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`IPR2022-00301 joined with IPR202 1-00880; IPR2022-00258 and
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`IPR2022-00298 joined with IPR2021-00881;PGR2021-00035 concerning
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`U.S. Patent 10,828,345; and appeals to the U.S. Court ofAppeals for the
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`Federal Circuit (“Fed. Cir.”or “Federal Circuit’) from the Board’s final
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`decisions in IPR2021-00880 and IPR2021-00881 in Regeneron
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`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 2023-1395, and
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`Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 2023-
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`1396. Paper 3, 1-2.
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`Regarding the above-noteddistrict court litigation, Regeneron
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`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. , NDWV-1-22-cv-
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`
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`IPR2023-00884
`Patent 11,253,572 B2
`
`00061, the evidence ofrecord indicates,inter alia: (1) Petitioner is not a
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`party to this litigation; (2) on April 19, 2023, the District Court entered an
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`Order on Claim Construction (discussed infra Section II.B); (3) on April 27,
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`2023, Patent Ownerexpressly stipulated to, inter alia, the invalidity ofthe
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`°572 patent’s claims 1—5, 8-11, 14, and 26—28, reserving rights to appeal;
`
`and (4)abenchtrial was held and all briefing, closing arguments, and post-
`
`trial briefing is concluded. Ex. 1063 (Order on Claim Construction);
`
`Ex. 2003 (Bench Trial Transcript); Ex. 2031 (Stipulation); Ex. 2032 (post-
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`trial brief); Prelim. Resp. 10-12. PatentOwnerstates that the parties now
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`“await the[D]istrict [C]ourt’sjudgment,” and “[a]n expedited appeal 1s
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`likely to follow.” Prelim. Resp. 11—12 (citing Ex. 2031; Ex. 2033; Ex. 2034,
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`20:11-19).
`
`C.
`
`THE ’572 PATENT
`
`The *572 patent issued on February 22, 2022, from U.S. Application
`
`17/352,892, which wasfiled on June 21, 2021. Ex. 1001, codes(45), (21),
`
`(22). The 572 patent ultimately indicates priority to U.S. Provisional
`
`Application 61/432,245, filed on January 13,2011. /d. at code (60), 1:7—29.
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`However,priority is an issue raised by the parties in this proceeding and we
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`discuss the matter below at Section II.C.
`
`The *572 patent’s abstractstates:
`
`The present invention provides methodsfor treating angiogenic
`eye disorders by sequentially administering multiple doses of a
`VEGFantagonist to a patient. The methods ofthe present
`invention include the administration ofmultiple doses of a
`VEGFantagonist to a patient at a frequency of once every 8 or
`more weeks. Themethods ofthe present invention are useful
`for the treatment of angiogenic eye disorders such as age related
`macular degeneration, diabetic retinopathy, diabetic macular
`
`
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`IPR2023-00884
`Patent 11,253,572 B2
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`edema, central retinal vein occlusion, branchretinal vein
`occlusion, and corneal neovascularization.
`
`Id. at Abstract.
`
`Asbackground, the ’572 patent states that “[r]elease ofvascular
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`endothelial growth factor (VEGF) contributes to increased vascular
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`permeability in the eye and inappropriate new vessel growth,” and
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`“inhibiting the angiogenic-promoting properties ofVEGFappears to be an
`
`effective strategy for treating angiogenic eye disorders.” /d. at 1:60-65. As
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`further background, the *572 patent identifies that “FDA-approved
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`treatments of angiogenic eye disorders such as AMD and CRVOincludethe
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`administration of an anti-VEGFantibodycalled ranibizumab (Lucentis®,
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`Genentech, Inc.) on amonthly basis by intravitreal injection.” /d. at 1:66—
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`2:2. The ’*572 patent indicates that its invention 1s a responseto theneedfor
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`“new administration regimes”of“less frequent dosing while maintaining a
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`high level of efficacy.” /d. at 2:6—9.
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`In summarizingits invention, the *572 patentstates:
`
`The present inventors have surprisingly discovered that
`beneficial therapeutic effects can be achieved in patients
`suffering from angiogenic eye disorders by administering a
`VEGFantagonist to a patient at a frequency of once every 8 or
`more weeks, especially when such dosesare preceded by about
`three doses administered to the patient at a frequency of about 2
`to4 weeks. Thus, according to the methods ofthe present
`invention, each secondary dose ofVEGFantagonist is
`administered 2 to 4 weeksafter the immediately preceding
`dose, and eachtertiary dose 1s administered at least 8 weeks
`after the immediately preceding dose.
`
`Id. at 2:22—-33. The *572 patent defines certain terms relevantto the above
`
`passage. The Specification states, for example, that “the VEGFantagonist
`
`comprises one or more VEGFreceptor-based chimeric molecule(s), (also
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`
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`IPR2023-00884
`Patent 11,253,572 B2
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`referred to herein as a “VEGF-Trap’ or ‘VEGFT’),” and that an exemplary
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`VEGFantagonist includes “aflibercept,” marketed as “EYLEA”by
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`Regeneron Pharmaceuticals, Inc. and approved by the FDA in November
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`2011, at a dose of 2 mg via intravitreal injection every 4 weeksfor three
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`months and then every 8 weeks.
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`/d. at 2:47—67.
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`Regarding a dosing regimen, the *572 patent further defines the terms
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`(ultimately used in the claims) “initial dose, “secondary doses,” and “tertiary
`
`doses” as follows:
`
`the “initial dose” is the dose whichis administeredat the
`beginning ofthe treatment regimen(also referred to as the
`“baseline dose’’); the “secondary doses”are the doses which are
`administered after the initial dose; and the “tertiary doses”are
`the doses which are administered after the secondary doses.
`
`Id. at 3:51-58. As discussed below at Section II.B.1, we interpret these
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`terms in accordance with these expressdefinitions in the Specification.
`
`The ’572 patent describes a series of Examplesdetailing clinicaltrials
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`conducted to validate the VEGFT drug andthe dosing regimen. /d. at 8:12—
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`18:3. Example4details two “Phase HI Clinical Trials ofthe Efficacy,
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`Safety, and Tolerability ofRepeated Doses ofIntravitreal VEGFT in
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`Subjects with Neovascular Age-Related Macular Degeneration” (AMD)
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`(Study 1 and Study 2), which employed a dosing regimenfor aflibercept
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`comprising an initial 2 mg dose, followed by two 4-week doses, and then
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`additional doses every 8-weeks through the end ofthe 52-week study (the
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`“2Q8”regimen). /d. at 9:29-14:30. The results ofthis and otherregimens
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`were compared to subjects administered 0.5 mg ranibizumab every 4 weeks
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`(the “RQ4”regimen) by assessing patients’ visual acuity based on a Best
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`Corrected Visual Acuity (BCVA)test, whichis based on the ability to
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`identify letters. /d. at 9:35—10:7. This disclosure describes the inclusion
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`6
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`IPR2023-00884
`Patent 11,253,572 B2
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`criteria and exclusioncriteria for the participating patients. /d. at 10:50—
`
`12:22.
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`Results ofthe Example 4 clinicaltrials are described in TABLE1,
`
`which wereproduce below:
`
`TABLE1
`
`
`Ranuaunab
`{8 me
`ontidy
`
`
`
`
`VRGPE
`
`
`
`
`
`ent @ viein* ete
`
`
`
`
`at 82 weeks versus Saactiae (o-vels
`
`
`
`bud auoiher af betters read cermectiy ay the Farky Treatment Dashets
`
`
`
`2 Ag
`
`
`
`
`
`ty marge at HSS, sing candideseeintervad gpymeach|
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`Id. at 13:9-27. According to the ’572 patent, these results showedthat the
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`VEGFT therapies usually maintained or improvedvisualacuity in patients
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`and were not inferior to the ranibizumabtreatment based on similarcriteria.
`
`Id. at 13:28-38.
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`As Example 5, the 572 patent describes a Phase 2 clinicaltrial using
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`the same drug, also administered at 2 mg doses and,in one arm ofthe trial,
`
`at a regimenofthree initial doses every four weeks followed by doses every
`
`eight weeks, but treating patients with diabetic macular edema (DME). /d.
`
`
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`IPR2023-00884
`Patent 11,253,572 B2
`
`at 14:32—15:5. The 572 patent describes that visual acuity in this trial was
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`maintained or improvedfor all VEGFT study groups. /d.
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`The ’572 patent concludes with 30 claims, ofwhich claims 1, 15, 26,
`
`and 29 are independentclaims. Ex. 1001, 23:2—25:5. Claim 1 is illustrative:
`
`1. A methodoftreating an angiogenic eye disorder in a
`patient in need thereof comprising sequentially administering to
`the patient by intravitreal injection a single initial dose of2 mg
`of aflibercept, followed by one or more secondary doses of
`2 mg ofaflibercept, followed by one or moretertiary doses of
`2 mg ofaflibercept;
`
`wherein each secondary dose is administered
`approximately 4 weeks following the immediately
`preceding dose; and
`
`wherein eachtertiary dose is administered
`approximately 8 weeks following the immediately
`preceding dose;
`
`wherein the patient achievesa gain in visual acuity
`within 52 weeksfollowingtheinitial dose.
`
`Ex. 1001, 23:2-14.
`
`Independentclaim 15 1s similar to claim 1 in reciting the same drug,
`
`dose, and dosing regimen,butis directed to “treating diabetic macular
`
`edema” (DME) and doesnot include any languagedirected to results. /d. at
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`23:53-64.
`
`Independentclaim 26 1s also similar to claim | in recitingthe same
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`drug, dose, and regimen,but addsthat the methodtreats “age related
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`macular degeneration” (AMD) andthat “the method 1s as effective in
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`achieving a gain in visual acuity as monthly administration of 0.5 mg of
`
`ranibizumabbyintravitreal injection in human subjects with age-related
`
`macular degeneration at 52 weeks following the initial dose.” Jd. at 24:26—
`
`44.
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`
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`IPR2023-00884
`Patent 11,253,572 B2
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`independent claim29 is also similar to claim 1, andis essentially the
`
`same as Claim 26, but differs in requiring effectiveness in “maintaime
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`visual acuity”rather than a gain therein. Jd. at 24:50-67.
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`D.
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`ASSERTED GROUNDSFOR UNPATENTABILITY
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`Petitioner asserts the following grounds for the unpatentabilityof
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`claims 1-30 of the °572 patent:
`
`Nov. 2010 PR?
`
`'
`
`1< 9,
`“
`1-85, 8-11, 16,17,
`20.21
`
`.
`
`20098 PR* ar Dec. 2010
`PR, 3 individually
`Dec. 2010 PR
`
`' The parties contest the priority date to be accorded the °572 patent:
`however, as explained herein, we agree with Patent Ownerthat all claims
`should be accorded at least a January 21, 2011, priority date, whichis before
`the ATA revisionsto 35 U.S.C. §§ 102 and 103 took effect on March 16,
`2013. 35US.C. $1060 (mote). Therefore, pre-AIA § 102 and § 103 apply.
`
`* Regeneron, Enrollment Completed in Regeneron and Bayer HealthCare
`Phase 3 Studies ofVEGF Trap-Eye in Neovascular Age-Related Macular
`Degeneration (Wet AMD) (Sept. 14, 2009} (Ex. 1005, “2609 PR").
`* Regeneron, Regeneron and Bayer Report Positive Results for VEGF Trap-
`Eye m Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and in
`Phase 2 Study in Diabetic Macular Edema (DME) (Dec. 20, 2010)
`(Ex. 1006, “Dec. 2010 PR”).
`
`* Regeneron, Bayer and Regeneron Repart Positive Top-Line Results of
`Two Phase 3 Studieswith VEGF Trap-Eyein Wet Age-related Macular
`Degeneration (Nov. 22, 2010) (Ex. 1007, “Nov. 2010 PR”).
`
`
`
`IPR?2023-00884
`Patent 11,253 572 B2
`
`2009 PR, Shams}!
`
`2009 PR.5007 ARVO!
`Dixon, 2010 ARVO®
`Dixon, Hecht,° 2006
`PR, Dec. 2010 PR
`Dec. 2010 PR, Hecht,
`2009 PR, 2007 ARVO,
`Dixon, 2010 ARVO
`Dixon, Dec. 2010 PR,
`CATT. PIER.
`
`3 James A. Dixonet5JamesA.Dixonetal.FVEGP Trap-Eveforthe treatmentofneovascular
`
`age-related macular degeneration, 18(10) EXPERT OPIN. INVESTIG. DRUGS
`1573-80 (2009) (Ex. 1009, “Dixon”).
`
`® Regeneron Pharm., Regeneron Reports Positive Phase | Data forthe
`VEGF Trap in Age-Related Macular Degeneration, Prelrmmaryresults show
`improvements in vision and retinal swelling, VEGF Trap was well tolerated
`at all dose levels, Companyalso announces initiation ofphase 2trial (May1,
`2006) (Ex. 1027, “2006 PR”).
`*D.V. Do et al.,ARVO Annual Meeting Abstract, Results ofa Phase I Study
`ofIntravitreal VEGF Trap in Subjects with Diabetic Macular Edema: The
`CLEAR-ITDME Study, 48 Investigative Ophthalmology &Visual Sci. 1430
`(May2007) (Ex. 1030,“2007 ARVO”).
`S.C. Major, Jr. & D.M. Brown, ARVO Annual Meeting Abstract, DA
`VINCE: DME and VEGFTrap-Eyve: Investigation ofClinical Impact: Phase
`2 Studyin Patients with Diabetic Macular Edema (DME), 5\ Investigative
`Ophthalmology & Visual Sci. 6426 (April 2010) (Ex. 1010, “2O1Q ARVO’).
`
`* Gerald Hecht, PhD, OphthalmicPreparations, in I] REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY,19" ed. Ch. 89, 1563-76 (Alfonso
`R. Gennaro ed., 1995) (Ex. 1016, “Hecht”)}.
`© CATT and PIERrefer to clinical trials conceming ranibizumab and
`bevacizumah, andare described in the Petition as encompassing Exhibits
`1020-1026.
`
`“WO 2006/047325 Al (published May4, 2006) (Ex. 1017, “Shams’”).
`
`10
`
`
`
`IPR?023-00884
`Patent 11,253 572 B2
`
`eseseeeere
`
`Dixon
`
`See Pet. 11-13.
`
`In support of these grounds for unpatentability Petitioner submits,
`
`infer alia, the Declaration afEdward Chaum, MD. Ex. 1602. Patent Owner
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`submits, iter alia, the Declaration ofRichard Manning. PhD, both in
`
`public-redacted form and in confidential-sealedform. Ex. 2061. In the
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`absence of evidence tothe contrary, we find on the record before usthat
`
`Drs. Chaum and Manning are competentto testify on the subject matter of
`
`their declarations. See Ex. 1002 €§ 5—13, 22-25; Ex. 1003, Ex. 1003; Ex.
`
`200] © ]-11, CV(at pages 139-150). Dr. Manning indicates he was
`
`retained by Patent Ownerto “testify concerning commercial success," a
`
`topic about which we findno argument in the Prelyminary Response. Ex.
`
`2001 © 9: see generally Prelim. Resp.
`
`Il. DISCUSSION
`
`Patent Owner describes Petitioner as taking a “kitchen sink approach”
`
`to the asserted unpatentability grounds, which we understand to be an
`
`argument that Petitioner is overly mclusive. Prelim. Resp. 20. As listedand
`
`summanzed above andin the Petition, Petitioner has expressly numbered
`
`eleven separate grounds for its unpatentability challenges. See supra Section
`
`LD: see also Pet. 11-13. However, depending upon howone interprets
`
`‘2 Michael J. Elmanetal., Randomized Trial Evaluating RanibizumabPlus
`Prompt or Deferred Laser or Tnameimolone Plus Prompt Laser for Diabetic
`Macular Edema, 117(6) OPHTHALMOLOGY 1064—77 (Tune 2010) (Ex. 1018,
`“Elman 2010").
`
`il
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`
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`IPR2023-00884
`Patent 11,253,572 B2
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`Petitioner’s challenges, there are potentially many more asserted
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`unpatentability grounds because the Petition includespriorart assertionsin
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`the alternative (e. g., anticipation by one reference or another) and reference
`
`combinationsin the alternative (e.g., obviousness over one reference
`
`individually or in view of anotheror several others) and, more than once,
`
`includes “and/or” conjunctions whenlisting proposed reference
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`combinationsasserted against claims(e.g., obviousness over one reference
`
`in view of oneor several others and/or anotherreference, or references, on
`
`occasion merely incorporated by reference from other grounds).
`
`Bystatute, petitions for interpartes review are requiredto identify
`
`“with particularity, each claim challenged, the grounds on which the
`
`challenge to each claim is based, and the evidence that supports the grounds
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`for the challenge to each claim.” 35 U.S.C. § 312(a)(3); see also 37 C.F.R.
`
`§ 42.104(b) (specifying necessary elements of a petition). Consistent with
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`such requirements, the Board’s Trial Practice Guide advisesthat petitioners
`
`should “avoid submitting a repository ofall the information that ajudge
`
`could possibly consider, and instead focus on concise, well-organized, easy-
`
`to-follow arguments supported by readily identifiable evidence ofrecord.”
`
`Consolidated Trial Practice Guide (Nov. 2019), at 39 (“CTPG’”).!3
`
`The particularity requirementis “ofthe utmost importance” because a
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`detailed and clear explanation ofthe challenge at the outset is necessary to
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`complete the trial within the statutorily prescribed timeframe. /ntelligent
`
`Bio-Systems, Inc. v. lumina Cambridge Ltd. , 82 F.3d 1359,1369 (Fed. Cir.
`
`2016). Moreover, as explained in Adaptics, the “all-or-nothing”nature of
`
`13 Available at www.uspto.gov/sites/default/files/documents/tpgnov.pdf.
`
`12
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`IPR2023-00884
`Patent 11,253,572 B2
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`institution decisions following SAS /nstitute Inc. v. Iancu, 138 S.Ct. 1348
`
`(2018), '* gives heightened importance to the statutory requirementfor
`
`particularity in an IPR petition. Adaptics Limited v. Perfect Co., IPR2018-
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`01596, Paper 20, at 17-18 (PTAB Mar.6, 2019) (informative) (quoting SAS
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`O&As (June 5, 2018), at Part D, Question D2).
`
`The petition at issue in Adaptics asserted ten prior art references
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`against nine patent claimsin five grounds, two ofwhich werefor
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`anticipation and three for obviousness. /d. at 2,6, 8-9. The three numbered
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`obviousness grounds, however, relied on “upto ten references connected by
`
`the conjunction “and/or,” which made the challenge unclear and resulted in
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`“a multiplicity of grounds” that were “voluminous and excessive.” /d. at
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`18-21. Accordingly, the Board deniedinstitution because the petition’ s
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`“lack of particularity... result[ed]in voluminous and excessive grounds.”
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`Td. at 18, 24.
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`Following Adaptics, the Board has consistently denied petitions that
`
`asserted inordinately large numbers of ambiguous grounds. See, e.g.,
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`EnergySource Minerals, LLC v. TerraLithium LLC, IPR2019-01607, Paper
`
`10 (PTAB May4, 2020) (denyinginstitution where the use of “and/or”in
`
`listing the references applied under obviousness groundsin the petition led
`
`to voluminous, excessive, andambiguous grounds); Sinjimoruv. Geneze
`
`4 See SAS, 138 S.Ct. at 1355 (holding that under § 314, the Board has “a
`binary choice—eitherinstitute review or don’t’); see also CTPG at 64 (“In
`instituting a trial, the Board will either (1) institute as to all claims
`challengedin the petition and onall groundsin the petition, or (2) institute
`on no claims and denyinstitution.”).
`'S Available at www.uspto.gov/sites/default/files/documents/
`sas_qas_20180605. pdf.
`
`13
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`IPR2023-00884
`Patent 11,253,572 B2
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`Innovation Inc. , {PR2021-00493, Paper 8 (PTAB July 28, 2021) (denying
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`institution where the petition purported to present 32 grounds, but, because
`
`manyofthose groundsasserted multiple statutory bases and multiple
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`combinations ofreferences, the petition actually advanced 205 different
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`grounds); Playtika Ltd. andPlaytika Holding Corp. v. NexRF Corp.,
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`IPR2021-00952, Paper 14, at 11, 12 (PTAB Nov.6, 2021) (denying
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`institution where the petition “challenges ten claims by combining eight
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`references in various permutationsto arrive at 96 grounds” and where the
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`groundsare unclear because petitioner “lumps together the discussion of
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`large numbers of grounds undera single heading” thereby obscuring the
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`specific arguments advanced); IPR2023-00738, Uber Technologies, Inc. et
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`al. v. Surgetech, LLC, Paper 8 (PTAB Oct. 23, 2023) (denyinginstitution
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`wherethepetition lumped together multiple groundsinto a single claim
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`chart that identified every prior art reference teaching any claim element
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`and, arguably, asserted thousandsofpossible unpatentability grounds).
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`The Petition here poses some ofthe same challenges found to bea
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`reason to denyinstitution in other cases before the Board. As noted above,
`
`there are potentially many more than the eleven numbered groundsasserted
`
`for unpatentability andthe style and wording of some ofPetitioner’s grounds
`
`suggest a questionable ambiguity in the Petition. Despite this potential
`
`infirmity, however, we find good reasonsto institute trial here.
`
`First, as discussed in detail below, we find that certain ofPetitioner’s
`
`grounds present compelling merits for the unpatentability of at least some
`
`challenged claims.
`
`Second, and importantly, Patent Owneridentifies Petitioner’s“kitchen
`
`sink approach,” but does not arguethat this should be a basis for denying
`
`14
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`IPR2023-00884
`Patent 11,253,572 B2
`
`institution. See generally Prelim. Resp. IfPatent Ownerdoesnotanticipate
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`it will be overly burdened in presenting a full defense against the challenges
`
`in the Petition, we will likewise undertake entering a final decision in this
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`matter.
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`Therefore, we interpret Petitioner’s grounds in a mannerso that we
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`may reasonably deal with each andall of the unpatentability challenges. We
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`will follow Petitioner’s expresslisting of grounds and include thereunder,
`
`respectively, any and all references listed under each numbered ground. For
`
`any proposed combinationofpriorart listed in the Petition’s summary of
`
`Grounds of Challenge weinterpret the asserted prior art combination to
`
`include every reference listed under thenumbered obviousness ground. For
`
`example, under Petitioner’s Ground V (5), we interpret the proposed
`
`combination ofreferences to include 2009 PR, 2007 ARVO, Dixon, and
`
`2010 ARVO because eachis listed under this Ground. If, under our final
`
`analysis in view of a completetrial record, certain references are found to be
`
`unnecessary to render a final decision on a challenge ofunpatentability,or if
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`certain references are shownto not be priorart (as presently asserted by
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`Patent Owner), we will so noteit in our final decision, as necessary.
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`Anyother mannerofinterpreting Petitioner’s obviousness grounds
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`would renderthe Petition overly ambiguous andtoo unwieldyto institute
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`trial. If, upon considering this and ouranalysis in this Institution Decision,
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`Petitioner determinesthat certain groundsfor unpatentability are no longer
`
`necessary to its case or do not require a final decision, we encourage
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`Petitioner to express/y abandon such challengesattrial.
`
`15
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`IPR2023-00884
`Patent 11,253,572 B2
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`A.|LEVEL OF ORDINARY SKILLIN THE ART
`
`In determining the level of ordinary skill in the art, we consider the
`
`types ofproblems encounteredin the art, the prior art solutions to those
`
`problems, the rapidity with which innovationsare made,the sophistication
`
`of the technology, andthe educational level of active workersin thefield.
`
`Custom Accs., Inc. v. Jeffrey-Allan Indus., Inc. , 807 F.2d 955, 962 (Fed. Cir.
`
`1986).
`
`Petitioner asserts that the level of ordinary skill in the art should be
`
`defined here consistent with related IPR2021-00881 concerning U.S. Patent
`
`9,254,338 and IPR2022-01226 concerning U.S. Patent 10,888,601, as
`
`follows:
`
`A POSAhere would have: (1) knowledge regarding the
`diagnosis and treatment of angiogenic eye disorders, including
`the administration oftherapies to treat said disorders; and
`(2) the ability to understand results and findings presented or
`published by othersin thefield, including the publications
`discussed herein. Typically, sucha person would have an
`advanceddegree, such as an M.D. or Ph.D. (or equivalent, or
`less education but considerable professional experience in the
`medical, biotechnological, or pharmaceutical field), with
`practical academic or medical experiencein (1) developing
`treatments for angiogenic eye disorders (such as AMD),
`including through the useofVEGFantagonists,or (11) treating
`of same, including through the use ofVEGFantagonists.
`
`Pet. 16—17 (citing Ex. 1002 49 22-25). This is also consistent with the
`
`proposed and adopted definition in IPR2022-01524. Patent Owner expressly
`
`adopts this proposeddefinition ofthe ordinarily skilled artisan for the
`
`purposesofthis proceeding(at this point). Prelim. Resp. 13.'°
`
`‘6 The parties use the acronym “POSA”to refer to the ordinarily skilled
`artisan. Prelim. Resp. 13; see also Pet. 40 (for example).
`
`16
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`IPR2023-00884
`Patent 11,253,572 B2
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`For the purposes ofthis Decision, we accept Petitioner’s proposed
`
`definition ofthe person of ordinary skill in theart (or ordinarily skilled
`
`artisan), which appearsto be consistent with the level of skill in the art
`
`reflected in the prior art ofrecord and the disclosure ofthe °572 patent. See
`
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the priorart
`
`itself [may] reflect|]” evidence ofthe ordinary level of skill in the art)
`
`(quotingLitton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`
`163 (Fed. Cir. 1985)).
`
`B.|CLAIM CONSTRUCTION
`
`The Board interprets claim terms in an interpartes review using the
`
`same claim construction standard used to construe claimsin a civil action in
`
`federal district court. 37 C.F.R. § 42.100(b). In construing claims,district
`
`courts andthe Boardhere, by default, give claim termstheir ordinary and
`
`customary meaning, which is “the meaningthat the term would have toa
`
`person of ordinary skill in the art in question at the time ofthe invention.”
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc).
`
`Should claim terms require express construction, sources for claim
`
`interpretation include “the words ofthe claims themselves, the remainder of
`
`the specification, the prosecution history[, 1.e., the intrinsic evidence], and
`
`extrinsic evidence concerning relevantscientific principles, the meaning of
`
`technical terms, andthe state oftheart.” /d. at 1314 (quoting /nnova/Pure
`
`Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed.
`
`Cir. 2004)). “[T]he claims themselves [may] provide substantial guidance as
`
`to the meaning ofparticularclaim terms.” /d. However, the claims “do not
`
`stand alone,” but are part of “‘a fully integrated written instrument’.
`
`. .
`
`consisting principally ofa specification that concludes with the claims,” and,
`
`17
`
`
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`IPR2023-00884
`Patent 11,253,572 B2
`
`therefore, the claims are “read in view of the specification.” /d. at 1315
`
`(quotingMarkman v. Westview Insts., Inc., 52 F.3d 967, 978-79 (Fed. Cir.
`
`1995) (en banc)). Any special definition for a claim term must be set forth
`
`in the specification “with reasonableclarity, deliberateness, and precision.”
`
`Inre Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Without such a special
`
`definition, however, limitations may not be read from the specification into
`
`theclaims. /nre Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
`
`“[WJe need only construe terms‘that are in controversy, and only to
`
`the extent necessary to resolve the controversy.” Nidec Motor Corp. v.
`
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`
`(Fed. Cir. 1999)).
`
`1.
`
`“initial dose,”
`
`9 66
`
`“secondary doses,” and “tertiary doses”
`
`Although neither party requests such expressinterpretation, for the
`
`sake of consistency with our decision denyinginstitution in IPR2022-01524,
`
`werepeat the following interpretations for claim language expressly defined
`
`in the °572 patent’s Specification.
`
`One or all of the terms“initial dose,”
`
`99 6¢
`
`“secondary doses,” and “tertiary
`
`doses,” are includedin every claim. See Ex. 1001, 23:1—25:5 (claims). The
`99 ¢¢
`
`°572 patent expressly defines the claim terms“initial dose,”
`
`“secondary
`
`doses,” and “tertiary doses,” in its Specification, as follows:
`99 ¢¢
`
`“secondary doses,” and “tertiary
`The terms “initial dose,”
`doses,” refer to the temporal sequence of administration ofthe
`VEGFantagonist. Thus, the “initial dose” is the dose whichis
`administered at the beginning ofthe treatment regimen (also
`referred to as the “baseline dose”’); the “secondary doses”are
`the doses which are administeredafter the initial dose; and the
`“tertiary doses”are the doses which are administeredafter the
`secondary doses. Theinitial, secondary, and tertiary doses may
`
`18
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`IPR2023-00884
`Patent 11,253,572 B2
`
`all contain the same amount ofVEGF antagonist, but will
`generally differ from one anotherin terms of frequency of
`administration. In certain embodiments, however, the amount
`of VEGFantagonist contained in the initial, secondary and/or
`tertiary doses will vary from one another(e. g., adjusted up or
`downas appropriate) during the course oftreatment.
`
`Pet. 16 (quoting Ex. 1001, 3:51—65; citing Ex. 1002 4 62).
`
`“When the specification explains and definesaterm used in the
`
`claims, without ambiguity or incompleteness, there is no need to search
`
`further for the meaning oftheterm.” Multiform Dessicants Inc. v. Medzam
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`Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998).
`
`The Specification ofthe °572 patent expressly and unequivocally
`99 ¢¢
`
`defines theclaim terms“initial dose,”
`
`“secondary doses,” and “tertiary
`
`doses,” as set forth in the quote above, as meaning, respectively,(1) the dose
`
`which is administered at the beginning ofthe treatment regimen; (2) the
`
`doses administeredafterthe initial dose; and (3) the doses administered
`
`after the secondary doses. We interpret these terms consistent with the
`
`Specification’s definitions.
`
`2.
`
`Preambles: “A methodoftreating...”
`
`There are three claim termsaddressed by the parties for claim
`
`construction,the first ofwhich concerns the preambles of independent
`
`claims 1, 15, 26, and 29, each ofwhichrecites “[a] method oftreating...” a
`>
`disorder “in a patient in need’”—“an angiogenic eye disorder”in claim 1,
`
`“diabetic macular edema” or DME in claim 15, and “age related macular
`
`degeneration” or AMD in claims 26 and 29 (although in claim 29 a hyphen
`
`is included between age and related). Ex. 1001, 23:2—7, 23:53-58, 24:26—
`
`31, 24:50—55 (independent claim preambles).
`
`19
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`IPR2023-00884
`Patent 11,253,572 B2
`
`Petitionerstates,
`
`[f]or the purposesofthis petition only, Petitioner does not
`contest that the preamble of challenged claims1, 15, 26, or 29
`is limiting, thoughit reserves theright to do so in separate
`proceedings. Petitioner proposes that the preamble be given the
`meaning of “a methodfortreating .
`. .” consistent with the
`meaning given to that term in the[final decision ofIPR2021-
`00881 concerning U.S. Patent9,254,338 andtheinstitution
`decision ofIPR2022-01226 concerning U.S. Patent
`10,888,601]. Ex.1011;Ex.1013. Petitioner further proposes
`that the claims not be construed to require a particular level of
`efficacy.
`
`Pet. 17-18 (citing Ex. 1001, 5:31-48, claims1, 8, 17, 21, 30; Ex. 1002
`
`44] 26-30, 80-85; Ex. 1011, 19, 23; Ex. 1013, 9-10; Ex. 1012, 10-12).
`
`To this, Patent Owner responds, “[f]or purposes ofthis Preliminary
`
`Response only, Patent Owner doesnot challenge Petitioner’s proposed
`
`construction ofthe preambles, Pet. 17-18.” Prelim. Resp. 13.
`
`Asthere is no dispute, and because we agree with Petitioner’s position
`
`on the claims’ preambles, which is consistent with the Board’s decisionsin
`
`other r
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